Beneficial Effects of Natural Products on Management of Xerostomia

Not Applicable

Completed

Conditions: Xerostomia
Diabetes Mellitus
Hypertension
Post COVID-19 Condition

Brief Summary: Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing.

Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.

Detailed Description: Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients suffering from that complaint which were based on the stimulation of the salivary gland flow. Salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists) Overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. This has strengthened the need for further investigation of other interventions for the management of xerostomia As Egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth.

Given the importance of the oral health status of in patients suffering from dry mouth with the associated problems, and the limited availability of proper remedy for xerostomia in the Egyptian market. This study is designed to evaluate the efficiency of different and natural treatment as a mix of (Manuka honey -green tea) mouth rinse in management of xerostomia.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

- Smoking, Alcohol.
Patient with history of any serious illness as malignancy.
Patients with any autoimmune disease.
Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Arm && Interventions

Group	Intervention	Description
(Manuka honey-green tea) interventional arm	(Manuka honey-green tea)	• (Manuka honey-green tea) will topically be applied to the oral mucosa as oral rinse 3 times per day to treat xerostomia.
Saline mouthwash control group	(Manuka honey-green tea)	Patients in the control arm followed the same protocol with normal saline rinses in the same bottles 3 times per day for xerostomia

Primary Outcome Measures

Name	Time	Method
Changes in subjective dry mouth score	one month	subjective dry mouth scores were calculated as the number of asked questions about dry mouth symptoms (0-4), and patients with a score higher than 1 considered having xerostomia so higher scores more than 1 out of 4 indicating xerostomia but lower scores suggesting improvement.

Secondary Outcome Measures

Name	Time	Method
Changes in objective dry mouth score	one month	Objective dry mouth scores were calculated as the number of observed dry mouth signs (0-5), and patients with a score higher than 2 having xerostomia so higher scores more than 2 out of 5 indicating xerostomia but lower scores suggesting improvement
Salivary Nitric oxide levels	one month	Increasing in the salivary nitric oxide levels indicating improvment
Salivary flow rates	one month	Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection will be timed, so that flow rate (mL/min) could be measure. increasing in the salivary flow rate of the unstimulated saliva is considered improvment